Pregart clinical trial situation in Uganda
The recruitment of trial participants on the Ugandan arm of the Pregart study kicked off on the 28th of September 2021 and it has been running to-date for approximately 17 weeks.
So far, the team has managed to enroll about 40 participants, of these, 3 have delivered, and all mothers and babies are faring well.
An unfortunate encumbrance in picking up recruitment numbers occurred mostly from the current global Covid-19 pandemic and the related setbacks. Solutions to mitigate this situation have been put in place for a hopefully better outcome. Aside from these overt challenges, the trial thus far is progressing steadily with a hope that it shall pick up to enable the team meet project’s end goals.
Update on Pregart clinical trial participant recruitment as of 13th October 2021
The Ugandan team started participant recruitment on 21st September 2021, with a total of 8 participants recruited to date. Prior to recruitment we had retraining of the Trial site staff on the Protocol, data collection tools and SOPs, to enable smooth understanding and running of participant recruitment.
Hawassa University Pregart clinical trial project PhD candidates presented their thesis concept note
One of the Pregart clinical trial project deliverable is clinical trial capacity building in Africa. Accordingly, one of the project consortium institutions, Karolinska Institute (KI) in Sweden will enroll 4 PhD and 2 -Post doc students from Hawassa University and Makerere University. Two of the PhD candidates from Hawassa university; Mr. Siraj Hussein from department of Medical Laboratory Science and Dr. Abel Gedefaw from School of Medicine presented their thesis concept note to their advisors on September 21/2021 at Hawassa University project office. Professor Eleni Aklilu from KI and Professor Eyasu Mekonnen from Addis Ababa University attended the presentation onsite at the office while Professor Stefano Vella from KI attended online using zoom. The PhD candidate’s registration process at KI will be completed in the coming two months.
Hawassa University President welcome Pregart clinical trial investigators
Hawassa University president, Dr. Ayano Beraso, warmly welcome Pregart clinical trial investigators on September 20/2021 at the president office. The visiting investigators, Professor Eleni Aklilu from Karolinska institute and Professor Eyasu Mekonnen from Addis Ababa university, has briefed the president on the trial implementation status progress and the recent activity plan. The President reassured to the team that he will continue following up of the project implementation in order to achieve the project deliverables.
Pregart project investigators conducted trial hospital site visit
Professor Eleni Aklilu from Karolinska institute, Professor Eyasu Mekonnen from Addis Ababa university with Hawassa University trial lead team members, conducted site visit to one of the trial site hospitals, Hawassa University Comprehensive Specialized hospital on September 20/2021. The investigators evaluated the quality of data collection, GCP compliant status during trial implementation and provide positive feedback to the team for future strengthening of the trial.
Pregart clinical trial Ethiopia trial lead team conducted project implementation status review meeting
A two-day review meeting, September 21-22/2021, was conducted on the Ethiopia Pregart clinical trial implementation status at the University project office. Most of the Ethiopia trial lead team (Dr. Birkneh Tilahin, Professor Eleni Aklilu, Professor Eyasu Mekoknnen , Dr. Abel Gedefaw , Dr. Dejene Hailu , Mr Siraj , Sintayehu Hailu , Negede Yohannes , Biruk kebede and others ) attended the meeting. The trial current implementation status, challenges and anticipated risks presented for discussion by three presentations. After in depth discussions, the trial lead team decided to initiate the trial recruitment in all the trial sites, fasten the recruitment process in the already initiated trial sites, finalize the PhD candidate’s thesis concept note, request protocol amendment to respective ethical and regulatory institutions to avoid protocol related bottlenecks of participant recruitment.
Pregart clinical trial project in Ethiopia has started participant recruitment in the third trial site
After the long impact of Covid-19 pandemic to the clinical trial implementation timeline, the Hawassa University trial lead team conducted site initiation visit from September 1-5/ 2021 and started participant recruitment per protocol at the third trial site in Bahirdar Felegehiwot Comprehensive Specialized hospital.
Pregart clinical trial project in Ethiopia has started participant recruitment in the second trial site
After the long impact of Covid-19 pandemic to the clinical trial implementation timeline, the Hawassa University trial lead team conducted site initiation visit from August 26-30/ 2021 and started participant recruitment per protocol at the second trial site in Gondor Comprehensive Specialized hospital.
Patient recruitment begins in Ethiopia after pandemic-related difficulties
The Covid-19 pandemic caused significant delays in starting the patient recruitment phase in both Ethiopia and Uganda. Finally, after intense work, patient recruitment finally began at Hawassa University Hospital on May 25, 2021. Recruitment work will now continue in the remaining hospitals in both Ethiopia and Uganda. Here are some pictures of the recruitment phase in Ethiopia.
PREGART Clinical Trial Database Development Training for Project Staff Using REDCap Software - Shasmene, Ethiopia, April 26-29, 2021
Main contents covered in the training were: Introduction to data, data quality, data quality dimensions; Introduction to REDCap software (Definitions, Important terminologies relevant to REDCap, REDCap features); Getting started with REDCap software; Creating New eCRF; Access & editing eCRF; Exporting data from REDCap to other Software.
Practical Session included: entering a fictitious data into the REDCap database; Identify limitations and errors in the CRFs created in the REDCap software; Identify data type as per the CRF; Save Data; Export Data variables; Edit and Save data dictionary (codebook).
Six project staff participated in the training: two trial site supervisors (one male and one female); two research team members; one clinical laboratory assistant; one project manager.